Change From Baseline in HbA1c Levels
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Exenatide (Bydureon) | -0.12 | 0.08 |
| Placebo | 0.11 | 0.10 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
NCT01928329Sept 2013 to Aug 2019
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of the proposed pilot study is to determine whether glucose control can be improved with Bydureon treatment in patients with type I diabetes (T1D)
Placebo comparator
Placebo
2 mg, 1 per week via subcutaneous placebo self injection
Experimental
Exenatide (Bydureon)
2 mg, of drug administration 1 per week via subcutaneous self injection
Outcomes the sponsor listed as primary.
Change From Baseline in HbA1c Levels
Time frame · 6 months
Change From Baseline in HbA1c Levels
Time frame · 12 months
Major Hypoglycemic Event Rate On Drug
Time frame · Up to 6 months
The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.
Major Hypoglycemic Event Rate Off Drug
Time frame · Up to 12 months
The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level \< 55 mg/dL.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Exenatide (Bydureon) | -0.12 | 0.08 |
| Placebo | 0.11 | 0.10 |
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Exenatide (Bydureon) | 0.08 | 0.09 |
| Placebo | 0.10 | 0.10 |
| Group | Value (events per month) |
|---|---|
| Exenatide (Bydureon) | 0.67 |
| Placebo | 0.80 |
| Group | Value (events per month) |
|---|---|
| Exenatide (Bydureon) | 0.33 |
| Placebo | 0.50 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide (Bydureon)2 mg, of drug administration 1 per week via subcutaneous self injection Exenatide (Bydureon®) | 0 / 39 | 6 / 39 | 39 / 39 |
| Placebo2 mg, 1 per week via subcutaneous placebo self injection Placebo | 0 / 35 | 2 / 35 | 28 / 35 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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